Trans-septal closure and port device

ABSTRACT

A septal closure and port device for implantation in the atrial septum of a patient&#39;s heart includes an expandable frame having a central portion defining a lumen, and first and second opposing end portions. The frame is configured to expand and contract between a compressed, tubular configuration for delivery through the patient&#39;s vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion. The device can further include a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame. The valve member is configured to permit a medical instrument to be inserted through the lumen and into the left atrium, such as for performing a subsequent medical procedure in the left side of the heart.

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication No. 62/291,258, filed Feb. 4, 2016, which is incorporatedherein by reference.

FIELD

The present disclosure relates generally to a method and device forclosing a septal defect, or opening in the septum. In particular, thepresent disclosure relates to a method and device for closing a septaldefect, for example a defect in an atrial septum, such that the septaldefect can be accessed for reentry through the defect.

BACKGROUND

A septum may include a thin wall dividing a cavity into two smallerstructures. An atrial septum is a wall of tissue separating the left andright atria of the heart. A ventricular septum is a wall of tissueseparating the left and right ventricles of the heart. A septal defectmay include a perforation or hole in the septum. A septal defect canoccur congenitally or by puncturing the septum with a medical device toaccess a location within the heart.

The femoral artery is an access point for many catheterizationlaboratory procedures, with a smaller percentage of procedures utilizingvenous or radial artery access. Likewise, the atrial septum is a pointof percutaneous access for atrial fibrillation therapy, left atrialappendage closure, percutaneous mitral valve repair, and percutaneousmitral valve replacement. In these and other procedures, devices maytraverse the atrial septum and, by doing so, may leave a defect ororifice in the atrial septum that cannot close or heal by itself.Therefore, these defects are often closed using devices, such as plugs.However, these devices do not allow for re-access through the septum.Thus a need exists for improved closure devices for closing a septaldefect and for re-accessing the left side of the heart in subsequentprocedures.

SUMMARY

In certain embodiments, the present disclosure describes a septal portdevice that is suitable for providing an access port to the left side ofthe heart with a catheter or other medical device. In certainembodiments, the port device is also suitable to close or repair aseptal orifice while allowing for re-entry through a septum at the sameseptal orifice location at a later time as other therapeuticinterventions are warranted.

In one representative embodiment, a septal closure and port device forimplantation in the atrial septum of a patient's heart comprises anexpandable frame comprising a central portion defining a lumen, andfirst and second opposing end portions extending from opposite ends ofthe central portion. The frame is configured to expand and contractbetween a compressed, tubular configuration for delivery through thepatient's vasculature and an expanded configuration in which the firstand second end portions extend radially outwardly from the opposite endsof the central portion and can compress the atrial septum there between.The device further comprises a valve member supported on the frame andpositioned to block at least the flow of blood from the left atrium tothe right atrium through the lumen of the frame. The valve member isconfigured to permit a medical instrument inserted in the right atriumto pass through the lumen and the valve member and into the left atrium,such as for performing a subsequent medical procedure in the left sideof the heart, for example, implanting a prosthetic mitral valve.

In another representative embodiment, a medical procedure comprisesinserting a delivery catheter into the vasculature of a patient, thedelivery catheter comprising a sheath containing a septal closure andport device in a compressed configuration; advancing at least a distalend portion of the sheath across the atrial septum of the patient'sheart; and deploying the closure and port device from the sheath suchthat a central portion of the closure and port device extends through anorifice in the atrial septum and first and second opposing end portionsof the closure and port device are deployed on opposite sides of theseptum, which is compressed between the first and second end portions.The closure and port device further comprises a valve member that blocksat least the flow of blood from the left to the right atrium through thecentral portion.

In some embodiments, the method can further comprise inserting a medicalinstrument through the valve member and performing a medical procedurein the left side of the heart using the medical instrument. In someembodiments, the medical instrument can comprise a delivery catheter anda prosthetic heart valve carried on a distal end portion of the deliverycatheter, and performing a medical procedure comprises implanting theprosthetic heart valve in the native mitral valve annulus of the heart.

The foregoing and other objects, features, and advantages of the presentdisclosure will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a septal closure and port device,according to one embodiment.

FIG. 2 is a perspective, exploded view of the closure and port device ofFIG. 1.

FIG. 3 is a perspective view of the frame of the closure and port deviceof FIG. 1.

FIG. 4 is a front elevation view of the closure and port device of FIG.1, as viewed from the proximal side of the device.

FIGS. 5-10 are side views of the distal end portion of a deliveryapparatus shown at various stages of an implantation procedure forimplanting the closure and port device of FIG. 1 in the atrial septum,according to one embodiment.

FIGS. 11-12 are cross-sectional views of the heart showing the closureand port device of FIG. 1 implanted in the atrial septum and a deliveryapparatus crossing the closure and port device to perform a procedure inthe left side of the heart.

FIG. 13 is a perspective view of a septal closure and port device,according to another embodiment.

FIG. 14 is a side view of the septal closure and port device of FIG. 13.

FIG. 15 is a front elevation view of the septal closure and port deviceof FIG. 13.

FIG. 16 is a cross-sectional view of the septal closure and port deviceof FIG. 13 taken along line 16-16 of FIG. 15.

FIG. 17 is a perspective view of the valve member of the septal closureand port device of FIG. 13 shown apart from the frame.

FIG. 18 is a perspective, exploded view of the valve member of FIG. 17.

FIG. 19 is a front view of a septal closure and port device, accordingto another embodiment.

FIG. 20 is a side perspective view of the septal closure and port deviceof FIG. 19.

FIG. 21 is a side perspective view of the valve member of the septalclosure and port device of FIG. 19 shown apart from the frame.

FIG. 22 is a side perspective view of a segment of the frame of theseptal closure and port device of FIG. 19.

DETAILED DESCRIPTION

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein.Features, integers, characteristics, compounds, chemical moieties orgroups described in conjunction with a particular aspect, embodiment orexample of the disclosure are to be understood to be applicable to anyother aspect, embodiment or example described herein unless incompatibletherewith. All of the features disclosed in this specification(including any accompanying claims, abstract and drawings), and/or allof the steps of any method or process so disclosed, may be combined inany combination, except combinations wherein at least some of suchfeatures and/or steps are mutually exclusive. The disclosure is notrestricted to the details of any foregoing embodiments. The disclosureextends to any novel one, or any novel combination, of the featuresdisclosed in this specification (including any accompanying claims,abstract and drawings), or to any novel one, or any novel combination,of the steps of any method or process so disclosed.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language. Forexample, operations described sequentially may in some cases berearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods can be used in conjunction with other methods.

As used herein, the terms “a”, “an”, and “at least one” encompass one ormore of the specified element. That is, if two of a particular elementare present, one of these elements is also present and thus “an” elementis present. The terms “a plurality of” and “plural” mean two or more ofthe specified element.

As used herein, the term “and/or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, and/or C” means “A”, “B,”, “C”, “A and B”, “A and C”, “Band C”, or “A, B, and C.”

As used herein, the term “coupled” generally means physically coupled orlinked and does not exclude the presence of intermediate elementsbetween the coupled items absent specific contrary language.

In certain embodiments, the present disclosure describes a septal portdevice that is suitable for providing an access port to the left side ofthe heart with a catheter or other medical device. In certainembodiments, the port device is also suitable to close or repair aseptal orifice while allowing for re-entry through a septum at the sameseptal orifice location at a later time as other therapeuticinterventions are warranted. As used herein, the term “septal orifice”or “orifice” is used to describe an orifice created by puncturing theseptum with a catheter or other medical device and an orifice thatoccurs congenitally, such as an atrial septal defect (ASD) or a patentforamen ovale (PFO).

FIG. 12 illustrates a heart shown in cross section having a septalorifice 10 in an atrial septum 12 between a left atrium 14 and a rightatrium 16. In the illustrated embodiment, the orifice 10 is created bypuncturing the septum 12 with a catheter, as described in detail below,for example, to repair or replace a valve or other tissue in the leftside of the heart. An exemplary port device 20 for implantation in theseptal orifice 10 is illustrated in FIGS. 1-4.

The port device 20 can include a frame 22 configured to support amembrane or valve member 24. The frame 20 can generally comprise a firstend portion 26, a second end portion 28, and a central portion 30between the first and second end portions. In its deployed state, thefirst and second end portions 26, 28 can extend radially outwardly fromthe central portion 30 (as shown in FIGS. 1-4), thereby forming opposingflange portions of the frame 22. The first and second end portions 26,28 can extend perpendicularly or substantially perpendicularly to thecentral axis of the device (the central axis extending through the lumenfrom the first end to the second end of the device) to compress or pinchthe atrial septum between the end portions 26, 28 when the device isimplanted in the atrial septum.

The frame 22 can be radially compressed or constricted to a deliveryconfiguration for delivery to the heart on a delivery apparatus, asshown in FIG. 6. In the delivery configuration, the frame 22 can beplaced and retained in a generally cylindrical or tubular configurationin which the first and second end portions 26, 28 are folded toward thecentral axis of the device such that they extend axially and parallel toeach other and the central portion 30. When placed in the deliveryconfiguration, the frame 22 can also be radially compressed relative tothe deployed configuration such that the lumen of the frame has areduced diameter relative to the diameter of the lumen in the deployedconfiguration.

The frame 22 can be self-expandable and can be formed from ashape-memory material, such as Nitinol, so that the frame 22self-expands from the delivery configuration to the deployedconfiguration when released or deployed from a delivery apparatus. Inalternative embodiments, the frame 22 can be formed from aplastically-expandable material, such as stainless steel orcobalt-chromium alloy, and can be configured to be plastically expandedfrom the delivery configuration to the deployed configuration by anexpansion device, such as an inflatable balloon.

The frame 22 in the illustrated embodiment comprises a plurality ofalternating struts 32, 34 extending between nodes or connecting portions36 (also referred to as apices) at the opposing ends of the frame. Aplurality of angularly spaced fingers 40 a and 40 b can be formed at thefirst and second end portions 26, 28, respectively, of the frame by thestruts 32, 34 and nodes 36. As best shown in FIG. 4, the fingers 40 a,40 b can be angularly offset from each other such that the fingers 40 aat the first end portion 26 of the frame are positionedcircumferentially between the fingers 40 b of the second end portion 28of the frame. Advantageously, this configuration can provide a greaterretaining or clamping force against the tissue surrounding the orifice10.

As best shown in FIG. 3, at the first end portion 26 of the frame, theend of each strut 34 can be connected directly to a respective node 36,and at the second end portion 28 of the frame, the end of each strut 34can be connected to two diverging secondary struts 38, which in turn canbe connected to respective adjacent nodes 36. Similarly, at the secondend portion 28 of the frame, the end of each strut 32 can be connecteddirectly to a respective node 36, and at the first end portion 26 of theframe, the end of each strut 32 can be connected to two divergingsecondary struts 38, which in turn can be connected to respectiveadjacent nodes 36. In this manner, the fingers 40 a, 40 b arrangedoffset relative to each other as shown in FIG. 4. In the illustratedembodiment, there are ten fingers 40 a, 40 b at each end of the frame22. The nodes 36 can have a circular shaped as shown, although othershapes can be used. In alternative embodiments, the struts 32, 34, 38and nodes 36 can be arranged such that the fingers 40 a, 40 b areangularly aligned with one another.

As shown in FIG. 4, the frame 22 in the deployed configuration caninclude an inner diameter (D1) and an outer diameter (D2). The innerdiameter D1 can be slightly less to slightly greater than that thediameter of the orifice 10 in the septum 12. The outer diameter D2 canbe defined by the circumference formed from the ends of the fingers 40a, 40 b. The number of fingers 40 at each end of the frame, the lengthof the fingers, and the inner and outer diameter of the frame can bevaried as needed for particular applications of the puncture frame.

In certain embodiments, the inner diameter (D1) can be between about 5mm and 15 mm, and more specifically, between about 6 mm and 12 mm, with10 mm being a specific example. The outer diameter (D2) can be betweenabout 12 mm and 36 mm, and more specifically, between about 20 mm and 30mm, with 30 mm being a specific example. The maximum spacing or width(S) (FIG. 3) between the outer ends of the fingers 40 a, 40 b can bebetween about 1 mm and 10 mm, and more specifically, between about 2 mmand 8 mm, with 3 mm being a specific example.

The valve member 24 can be configured to block the flow of blood betweenthe right and left atria through the port device 20 but permit passageof a medical device through the lumen of the port device. For an adult,the normal range of right atrial pressure (RAP) is about 2-6 mmHg andthe normal range of left atrial pressure (LAP) is about 4-12 mmHg. Thus,throughout most of the cardiac cycle, the LAP is greater than the RAP.In some embodiments, the valve member 24 can be configured to block atleast the flow of blood from left atrium to the right atrium. In otherembodiments, the valve member 24 can be configured to block the flow ofblood between the right and left atria in both directions throughout thecardiac cycle.

The valve member 24 in the illustrated embodiment comprises a pluralityof overlapping “leaflets” or flaps 42 a, 42 b, 42 c that are arrangedrelative to each other to maintain a closed position against a bloodpressure gradient between the right atrium 16 and the left atrium 14 butcan be opened by the force of a catheter or other medical instrument topermit passage of the medical instrument through the lumen of the portdevice 20. The flaps primarily block the flow of blood from the leftatrium to the right atrium due to the typically higher LAP, but can alsoblock the flow of blood from the right atrium to the left atrium if theRAP exceeds the LAP. The plurality of overlapping flaps 42 a, 42 b, 42 ccan also be described as forming an expandable hole 48, the hole 48having a closed configuration to block at least the flow of blood fromthe left atrium to the right atrium through the hole 48 and an expandedconfiguration to permit a medical instrument inserted in the rightatrium to pass through the lumen and the valve member and into the leftatrium.

Each flap 42 a-42 c can comprise an angular wedge-shaped or pie-shapedsegment comprising an outer peripheral edge portion 44 and radiallyextending side edge portions 46. The flaps 42 a-42 c can be secured tothe first end portion 26 of the frame 22 using suitable techniques ormechanisms known to those skilled in the art with the benefit of thepresent disclosure. For example, outer peripheral edges 44 of the flaps42 a-42 c can be secured to the fingers 40 a, such as with sutures, anadhesive, and/or welding. As depicted in FIG. 4, each of the radiallyextending edge portions 46 of a flap can overlap an adjacent edgeportion 46 of an adjacent flap. FIG. 4 shows the arc length of each flapand depicts each flap in a different line pattern to show theoverlapping relationship of the flaps. Also, the radially extending edgeportions 46 of the flaps can be unattached to the frame 22 and to eachother. In some embodiments, the radially extending side edge portions 46can be secured to each other or to the frame proximate the outerperipheral edge portions 44 so long as the flaps can be opened by theforce of a medical instrument inserted through the lumen of the device.

Although three flaps 42 a-42 c are shown in the illustrated embodiment,a greater or fewer number of flaps can be used in alternativeembodiments. Also, the flaps 42 a-42 c can be equally sized and shaped,while in other embodiments the flaps can comprise different sizedangular segments. In particular embodiments, for example, each flapcomprises an angular segment that has an angle greater than 90 degreesbetween the radially extending sides, such as about 100 to 120 degrees.In other embodiments, each flap 42 a-42 c can subtend a different anglebetween the radially extending sides.

The flaps 42 a-42 c can be formed from any of various suitablematerials, including natural tissue or synthetic materials, such as anyof various woven (e.g., fabric) or non-woven materials made from any ofvarious polymeric materials. Some examples of natural tissue include,for example, bovine, porcine, or equine pericardial tissue orpericardial tissue from other animals. Some examples suitable polymericmaterials include, for example, polyurethane or polyester. In onespecific example, the flaps can comprise polyethylene terephthalate(PET) fabric.

The port device 20 in the illustrated embodiment includes a valve member24 mounted to the first end portion 26 of the frame 22. In alternativeembodiments, a valve member 24 can be mounted to the second end portion28 of the frame or to both the first and second end portions 26, 28 ofthe frame. In other embodiments, a valve member 24 can be mounted withinthe central portion 30 of the frame.

In alternative embodiments, valve members having different constructionscan be incorporated in the port device 20. In one implementation, forexample, a valve member can comprise a slit valve comprising one of morelayers of material with each layer of material having a slit or openingformed at its center to permit passage of a medical device (e.g., asshown in the embodiment of FIGS. 13-18, described below) and prevent orminimize the flow of blood through the valve member when the medicaldevice is removed. In still alternative embodiments, the valve member 24can comprises one or more metal struts pivotally connected to the frame22 (e.g., to the central portion 30 of the frame such as by hinges) andcovered with a blood-impermeable material, such as a woven or non-wovenpolymeric material or natural tissue. The metal struts can be biased tomaintain a closed position blocking the flow of blood between the rightand left atria (in one or both directions) but can be pushed open by theforce of the distal end of a medical instrument inserted through thelumen of the port device.

In some embodiments, the port device 20 can include a cover or skirtthat covers the metal struts of the frame or selected portions of themetal struts, such as to promote tissue in-growth. The cover can beformed from any of various suitable materials, including natural tissueor synthetic materials, such as any of various woven (e.g., fabric) ornon-woven materials made from any of various polymeric materials,including any of the materials discussed above in regards to the flaps42 a-42 c of the valve member (e.g., PET fabric). As discussed in detailbelow in connection with the embodiment of FIGS. 13-16, the cover cancomprise strips of fabric or another suitable material placed only alongthe outer peripheral edges of the first and second end portions 26, 28of the frame to promote tissue in-growth at those locations of theframe.

FIGS. 5-9 illustrate one example of delivering and implanting the portdevice 20 using an exemplary delivery apparatus 100. The deliveryapparatus 100 can generally comprise an outer sheath 102, an inner shaft104 (FIG. 8) extending co-axially through the outer sheath 102, and anose cone 106 mounted to the distal end portion of the inner shaft 104.The inner shaft 104 and the nose cone 106 can include a lumen sized toallow the delivery apparatus 100 to be advanced over a guidewire 108.The proximal ends of the sheath 102 and the inner shaft 104 can becoupled to a handle (not shown) having appropriate actuators (e.g.,knobs) to effect relative longitudinal movement of the outer sheath 102and the inner shaft 104.

Prior to implantation, the port device 20 can be radially compressed tothe delivery configuration and loaded into the distal end portion of thesheath 102. The delivery apparatus 100 can be advanced percutaneouslythrough the patient's vasculature to the right atrium 16 of the heart ina trans-septal, antegrade approach for implanting the port device 20 inthe septum 12. In one approach, the delivery apparatus 100 can beadvanced through a femoral vein, the inferior vena cava, and into theright atrium. In another approach, the delivery apparatus can beadvanced through a vein of the upper torso (e.g., a jugular vein), thesuperior vena cava, and into the right atrium.

Once in the right atrium, the delivery apparatus 100 can be advancedthrough the septum 12 to position the nose cone 106 and a distal endportion of the sheath 102 in the left atrium 14, as shown in FIG. 5. Ifthere is an existing orifice 10 in the septum (e.g., from a congenitaldefect), the delivery apparatus 100 can be advanced through the orifice10. If the port device 20 is being used to provide an access port in ahealthy septum to perform a procedure on the left side of the heart, theguidewire 108 and/or the nose cone 106 can be used to puncture theseptum 12 and create an orifice 10.

As shown in FIGS. 6 and 7, the sheath 102 can then be retractedproximally to deploy the first end portion 26 of the port device,allowing the first end portion 26 to radially expand. The inner shaft104 and the nose cone 106 can be advanced distally during deployment ofthe first end portion 26. The entire delivery apparatus 100 can then beretracted slightly to bring the expanded first end portion 26 againstthe septum 12 within the left atrium, as shown in FIG. 7. Thereafter, asshown in FIG. 8, the sheath 102 can be further retracted to deploy thecentral portion 30 and the second end portion 28, allowing the secondportion 28 to radially expand against the septum 12 in the right atrium,leaving the port device 20 implanted in the orifice 10 in the septum.The clamping force of the fingers 40 a, 40 b against the opposing sidesof the septum can retain the port device in the orifice.

Following deployment, as shown in FIGS. 9-10, the nose cone 106 can beretracted back through the valve member 24 and the central portion 30 ofthe port device 20 to mate with the distal end of the sheath 102, afterwhich the delivery apparatus 100 can be removed from the patient's body.As discussed above, when the delivery apparatus is removed, the valvemember 24 can move to a closed position to block the flow of bloodbetween the right atrium and the left atrium. The guidewire 108 can beleft in place if another medical instrument is to be used to access theleft side of the heart in a subsequent procedure.

FIGS. 11 and 12 are two cross-sectional views of the heart showinganother delivery apparatus 200 being advanced through the port device 20to access the left side of the heart in a trans-septal procedure. FIGS.11 and 12 show the delivery apparatus 200 extending through the inferiorvena cava into the right atrium 16 and through the valve member 24 ofthe port device 20. The flaps 42 a-42 c can form a seal around the outersurface of the delivery apparatus 200 to prevent or at least minimizeblood flow through the port device 20 when the delivery apparatusextends through the valve member 24. It can be appreciated that the pathof the delivery apparatus 200 shown in FIGS. 11 and 12 also representsthe delivery path of the delivery apparatus 100 when advancedtrans-septally to the heart via the inferior vena cava.

A conventional trans-septal delivery technique of a catheter designed topuncture the septum 12 may involve pushing the catheter such that aportion of the catheter leans against the right atrial wall until itsdistal end “falls” into or engages the fossa ovalis dent in the rightatrial side of the septum, which is the desired puncture site on theseptum. The port device 20 mimics the native anatomy of the septum inthat the central portion 30 forms a dent relative to the second portion28 of the frame to facilitate crossing of the port device using aconventional trans-septal medical instrument. The struts 32, 34 cancurve as they transition from the end portions of the frame to thecentral portion 30, which helps guide the distal end of a medicalinstrument through the port device as the medical instrument is pushedthrough the right atrium.

The delivery apparatus 200 can be, for example, a delivery apparatus fordelivering and implanting a prosthetic heart valve in the native mitralvalve or the native aortic valve. In alternative embodiments, thedelivery apparatus 200 can be used to deliver and implant various otherprosthetic devices in the left atrium, mitral valve, left ventricle,and/or the aortic valve, including, for example, annuloplasty rings,closure devices for the left atrial appendage, sealing devices orreshaping devices for repairing or reshaping portions of the heart. Inother embodiments, other percutaneous medical instruments can beadvanced through the port device 20 for performing a procedure on theleft side of the heart, such as atrial fibrillation therapy.

FIGS. 13-16 show a port device 300, according to another embodiment. Theport device 300 generally comprises a frame 302 and a valve member 304supported by the frame 302. In its deployed configuration, the frame 302can generally comprise first and second flange portions 306, 308,respectively, extending radially outwardly from a central portion 310.Similar to the port device 20 described above, the port device 300 canbe radially collapsed to a tubular delivery configuration and placedinside the sheath of a delivery apparatus for delivery and implantationin the atrial septum 12.

The frame 302 can comprise a plurality of frame members 312 that can beencapsulated by an encapsulating layer 314. Each frame member 312 cancomprise an enclosed wire-form structure that extends from one end ofthe port device 300 to the other end of the port device 300. First endportions 316 of the frame members 312 form a first set of radiallyextending fingers and second end portions 318 of the frame members 312form a second set of radially extending fingers. The first flangeportion 306 thus can be formed by the first fingers 316 and the portionof the encapsulating layer 314 encapsulating the first fingers 316.Similarly, the second flange portion 308 can be formed by the secondfingers 318 and the portion of the encapsulating layer 314 encapsulatingthe second fingers 318. The central portion 310 of the frame 302 can beformed from intermediate portions 320 of the frame members 312 and theportion of the encapsulating layer 314 encapsulating the intermediateportions 320.

In the illustrated embodiment, the frame members 312 are discrete framemembers that are not interconnected to each other with metal struts orother metal frame members. This allows the central portion 310 to moreeasily expand radially to accommodate a relatively larger medicalinstrument inserted through the port device 300, as further describedbelow. In other embodiments, the frame 302 can include metal struts orframe members interconnecting the frame members 312.

The encapsulating layer 314 can be made of any suitable biocompatiblematerial. In one example, the encapsulating layer 314 can be formedusing an electrospinning process. In other examples, the encapsulatinglayer 314 can be formed using any other suitable method including, forexample, dip coating, spray coating, or melt-spinning. The biocompatiblematerial may be a non-absorbable polymeric material (i.e., a materialthat does not dissolve once implanted in the body), preferably anelastomer. The material for forming the encapsulating layer 314 can beselected to prevent or minimize tissue in-growth and integration of theport device with adjacent tissue. Examples of suitable materialsinclude, without limitation, polytetrafluoroethylene (PTFE),polyethylene (e.g., ultrahigh molecular weight polyethylene (UHMWPE)),silicones (e.g., silicone rubber), polyurethane, or various combinationsof any of these materials. In some embodiments, the encapsulating layercan be treated or can be coated with an outer layer to induce sometissue in-growth with the flanges 306, 308.

In particular embodiments, the encapsulating layer 314 can comprise afirst, inner layer and a second, outer layer formed from respectivetubes made of a suitable polymeric material (e.g., PTFE tubes or UHMWPEtubes). The frame members 312 can be placed co-axially between the innerand outer layers, which can then be bonded to each other when subjectedto heat and/or pressure treatment to form a laminate.

The frame 302 can further include fabric or cloth strips 322 coveringthe outer peripheral edge portions of the first and second flanges 306,308. As best shown in FIG. 16, each strip 322 can be wrapped around aperipheral edge portion of a flange 306, 308 so as to form an innerlayer 324 on the inside of the flange and an outer layer 326 on theoutside of the flange. The strips 322 can be formed from any of varioussuitable biocompatible fabrics, such as PET. The strips 322 can besecured to the frame 302, for example, by suturing the strips 322 to theframe members 312 and/or the encapsulating layer 314. The strips 322promote tissue in-growth of the port device 300 only along theperipheral edge portions of the flanges 306, 308.

The valve member 314, like the valve member 24, can be configured toretain a closed configuration when a medical instrument is not insertedthrough the valve member in order to block blood flow between the rightand left atria in both directions. As best shown in FIGS. 17-18, thevalve member 314 in the illustrated embodiment can comprise one or morelayers of disc-shaped valve elements 328 a, 328 b, 328 c, 328 d, 328 estacked against each other. Although five valve elements 328 a-328 e areused in the illustrated embodiment, the valve member 314 can have feweror greater number of valve elements 328. The valve elements can be madeof a biocompatible polymeric material and/or elastomer, such as any ofthe materials mentioned that can be used to form encapsulating layer314. As best shown in FIG. 16, the valve member 314 can be supported atthe center of the lumen of the central portion 310 of the frame 302. Thevalve member 314 can be secured to the frame 302, for example, bywelding, an adhesive, and/or sutures.

Each valve element 328 a-328 e can include an aperture or slit to permitpassage of a medical instrument through the valve member 314. In someembodiments, the aperture or slit can be expandable. In the illustratedembodiment, for example, the outer valve elements 328 a, 328 e can beformed with centrally located apertures 330, while the inner valveelements 328 b, 328 c, 328 d can be formed with slits or cuts 332, suchas cross-shaped or x-shaped slits as shown.

The slits 332 of adjacent valve elements can be angularly orrotationally offset from each other to enhance sealing of the valvemember 314 in a closed state. For example, the slits 332 of the centralvalve element 328 c can be rotationally offset from the slits 332 of thevalve element 328 b by about 90 degrees, and the slits 332 of the valveelement 328 d can be rotationally offset from the slits 332 of thecentral valve element 328 c by about 90 degrees. The outer valveelements 328 a, 328 e can be formed with apertures 330 rather than slitsto prevent fluttering or movement of the flaps of the inner valveelements 328 b, 328 c, 328 d against a blood pressure gradient acrossthe valve member 314. In some embodiments, the aperture/slits of eachvalve element can be radially offset with respect to the aperture/slitsof an adjacent valve element to further enhance sealing of the valvemember in the closed state. For example, one valve element can have anaperture/slits located at the center of the valve element while anadjacent valve element can have an aperture/slits offset from the centerof the valve element.

The port device 300 can be implanted in an orifice 10 of a septum 12using the delivery apparatus 100 and methods described above inconnection with the port device 20. The spacing between the flanges 306,308 is selected such that the flanges provide a pinching or compressionforce against opposing sides of the septum 12 to anchor the port device300 in place. After implantation in the septum, additional medicalinstruments (e.g., a delivery apparatus 200) can be inserted through theport device to perform a subsequent procedure on the left side of theheart.

The valve elements 328 a-328 e can form a seal around a medicalinstrument (e.g., a delivery catheter) inserted through theapertures/slits of the valve elements to prevent blood flow between theright and left atria during a subsequent medical procedure. As describedabove, the central portion 310 of the port device 300 can expandradially when the medical instrument is passed through the port device300. Thus, the inner diameter D1 (FIG. 16) of the central portion 310can be smaller than the outer diameter of a medical instrument thatwould be inserted through the port device 300 in a subsequent procedure.

As described above, the material used to form the encapsulating layer314 can be selected to prevent or minimize tissue in-growth with thecontacting faces of the flanges 306, 308 (the faces or surfaces of theflanges contacting the septum). If the flanges 306, 308 have fabricstrips 322 along their peripheral edges, there can be relatively lesstissue in-growth (or no tissue in-growth) across the central surfacearea of the flanges bounded by the strips 322 compared to the tissuein-growth that occurs along the strips 322. Thus, in particularembodiments, the majority of the surface area of the contacting faces ofthe flanges 306, 308 promotes little or no tissue in-growth. Minimizingthe tissue in-growth across the surface area of the flanges 306, 308 isadvantageous in that it minimizes stress on the tissue of the septum 12when a medical instrument inserted through the port device causesexpansion of the port device.

In alternative embodiments, any of the embodiments disclosed herein canbe configured to function primarily as a closure device and notnecessarily to facilitate multiple re-access through the septum. Forexample, the valve members 24, 304 of devices 20, 300 can be replacedwith a flow-blocking member, such as sheet of fabric or tissue (e.g.pericardium), that blocks the flow of blood through the device but isnot moveable or formed with any openings to permit passage of a medicalinstrument there through.

In some embodiments, the flow-blocking member can be punctured with amedical instrument if access through the septum is needed in asubsequent procedure. If the medical instrument has a relatively smalldiameter, such as used for treating arrhythmias, the hole formed in theflow-blocking member may be small enough to sufficiently inhibit bloodflow between the left and right atria without further intervention. Ifthe medical instrument has a relatively large diameter, such as adelivery apparatus for implanting prosthetic valve, and leaves arelatively larger opening in the flow-blocking member, another portand/or closure device can be implanted within the first closure deviceto block blood flow between the right and left atria.

FIGS. 19-20 show a port device 400, according to another embodiment. Theport device 400 generally comprises a frame 402 and a valve member 404supported by the frame 402. In its deployed configuration, the frame 402can generally comprise first and second portions 406, 408, respectively,extending radially outwardly from a central portion 410. Similar to theport device 20 described above, the port device 400 can be radiallycollapsed to a tubular delivery configuration and placed inside thesheath of a delivery apparatus for delivery and implantation in theatrial septum 12. When implanted, a resilient band member 424 of thevalve member 404 may lie approximately in the plain of the septum 12.

The frame 402 in the illustrated embodiment comprises a wire form shapeincluding a plurality of angularly spaced fingers 412 and 414 formed atthe first and second end portions 406, 408, respectively, of the frame.As best shown in FIG. 20, the fingers 412, 414 can be angularly offsetfrom each other such that the fingers 412 at the first end portion 406of the frame are positioned circumferentially between the fingers 414 ofthe second end portion 408 of the frame. Advantageously, thisconfiguration can provide a greater retaining or clamping force againstthe tissue surrounding the orifice 10. In alternative embodiments, frame402 can be arranged such that the fingers 412, 414 are angularly alignedwith one another.

As best shown in FIG. 22, the frame 402 can also be described ascomprising a plurality of connected segments 416 connected side-by-sideto form a ring structure. Each segment 416 can include a section of thefirst end portion 406, the second end portion 408 and the centralportion 410. The second end portion 408 can comprise two wire forms 420a and 420 b extending from the central portion 410, the two wire forms420 a and 420 b curving away then towards one another to form one of thefingers 414. The first end portion 406 can comprise two wire forms 418 aand 418 b extending from the central portion 410, the two wire forms 418a and 418 b extending away from one another. One of the ends of the twowire forms 418 a and 418 b can be joined with an end of another segment416 to form one of the fingers 412.

As best shown in FIG. 21, the valve 404 can comprise a tubular member422 and an expandable band member 424 that can be centrally disposedaround a central portion 430 of the tubular member 422 to form anexpandable hole 428 (FIG. 19). The tubular member 422 can includeopposing edge portions 426 that can be attached to the frame 402 bymeans known to those skilled in the art with the benefit of thisdisclosure, for example by suturing, welding, and/or adhesive bonding.

The tubular member 422 may comprise a suitable biocompatible material,such as any of those materials discussed above for forming flaps 42 a,42 b, 42 c of the port device 20 or encapsulating layer 314 of the portdevice 300. For example, the tubular member 422 may comprise a woven(e.g. fabric) material, such as PET fabric. Additionally and/oralternatively, the tubular member 422 may comprise natural tissue orsynthetic materials, such as any of various non-woven materials madefrom any of various polymeric materials. The tubular member 422 caninclude a low coefficient of friction to allow for smooth passage ofcatheters or other instruments, for example, the tubular member cancomprise a tubular sheet of PTFE or UHMWPE. Additionally and/oralternatively, the tubular member 422 can enable tissue ingrowth on itssurface. The band member 424 can comprise any of various suitablebiocompatible elastomers, such as PTFE, polyethylene, silicone, orpolyurethane.

In some embodiments, the tubular member 422 can comprise an outer fabriclayer and an inner polymeric layer formed from a material having arelatively lower coefficient of friction, such as PTFE or UHMWPE.

The band member 424 can have an expanded diameter and an unexpandeddiameter. The band member 424 can comprise a biocompatible elastomericmaterial and can have sufficient elongation properties to seal the valve404 yet also allow for passage of catheters or other instruments. Forexample, the elongation properties of the band member 424 can be greaterthan 300%. When a catheter or other instrument is advanced through thehole 428, the band member 424 can expand such that the hole 428 canexpand to allow the instruments crossing. The tubular member 422 canenable smooth advancement of the catheter or other instrument, forexample via a low friction material. When the catheter or otherinstrument is retracted, the band member 424 can relax and reseal thecentral hole 428.

The band member 424 surrounds and contracts the central portion 430 ofthe tubular member 422. The excessive material of the central portion430 gathered by the band member 424 collects to seal the central hole428. The “free” diameter of the tubular member 422 (i.e. the diameter ofthe tubular member without the band member) can be approximately thesame as the diameter of the central portion 410 of the frame 402.

In some embodiments, the band member 424 can seal the central portion430 against the outer surface of the medical instrument (e.g., catheter200) inserted through the port device 400 to prevent or minimize bloodflow through the opening 428 when the medical instrument is insertedthrough the opening. In the illustrated embodiment, the band member 424is configured such that the opening 428 does not completely close whenthe medical instrument is removed from the port device and may allow asmall amount of blood flow between the left atrium and right atriumthrough the opening 428. In alternative embodiments, the band member 424is configured to completely close the opening 428 when the medicalinstrument is removed from the port device and prevent blood fromflowing between the left atrium and right atrium through the opening428.

In view of the many possible embodiments to which the principles of thedisclosed technology may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the disclosureand should not be taken as limiting the scope of the disclosure. Rather,the scope of the disclosure is defined by the following claims. Wetherefore claim as our disclosure all that comes within the scope andspirit of these claims.

We claim:
 1. A method, comprising: inserting a delivery catheter intothe vasculature of a patient, the delivery catheter comprising a sheathcontaining a septal closure and port device in a compressedconfiguration; advancing at least a distal end portion of the sheathacross an atrial septum of the patient's heart; and deploying theclosure and port device from the sheath such that a central portion ofthe closure and port device extends through an orifice in the atrialseptum and first and second opposing end portions of the closure andport device are deployed on opposite sides of the septum, which iscompressed between the first and second end portions, wherein theclosure and port device further comprises a valve member that blocks atleast the flow of blood from the left to the right atrium through thecentral portion.
 2. The method of claim 1, further comprising insertinga medical instrument through the valve member and performing a medicalprocedure in the left side of the heart using the medical instrument. 3.The method of claim 2, wherein the medical instrument comprises adelivery catheter and a prosthetic heart valve carried on a distal endportion of the delivery catheter, and performing the medical procedurecomprises implanting the prosthetic heart valve in the native mitralvalve annulus of the heart.
 4. The method of claim 2, wherein the valvemember forms a seal around the outer surface of the medical instrument.5. The method of claim 2, wherein inserting the medical instrumentthrough the valve member causes the central portion of the closure andport device to expand radially.
 6. The method of claim 1, wherein thevalve member blocks the flow of blood between the left atrium and rightatrium in both directions.
 7. The method of claim 1, further comprisingcreating the orifice in the septum by puncturing the septum prior todeploying the closure and port device.
 8. The method of claim 1, whereinthe closure and port device comprises an expandable frame defining thecentral portion and the first and second opposing end portions, andwherein the valve member is supported on the frame and is configured topermit a medical instrument inserted in the right atrium to pass througha lumen in the central portion and the valve member and into the leftatrium.
 9. The method of claim 8, wherein the frame comprises aplurality of metal frame members.
 10. The method of claim 9, whereineach of the first and second end portions comprises a plurality ofcircumferentially spaced fingers formed by the metal frame members. 11.The method of claim 9, wherein the frame members are encapsulated in apolymeric material.
 12. The method of claim 1, wherein the first andsecond end portions comprise annular flanges that extend substantiallyperpendicular to the central portion.
 13. The method of claim 12,further comprising fabric strips covering outer peripheral edge portionsof the flanges to induce tissue in-growth with the covered portions ofthe flanges.
 14. The method of claim 13, wherein each flange comprisesan inner surface area bounded by a respective fabric strip, the innersurface area formed from a polymeric material that induces relativelyless tissue in-growth than the fabric strip.
 15. The method of claim 1,wherein the valve member is secured to the first end portion and extendsacross a lumen of the central portion.
 16. The method of claim 1,wherein the valve member comprise a plurality of flaps, each comprisingan angular segment having an outer circumferential edge portion and tworadially extending edge portions, the circumferential edge portionsecured to the first end portion and each radially extending edgeportion placed in an overlapping relationship with an adjacent radiallyextending edge portion of an adjacent flap, wherein a medical instrumentcan be inserted through the flaps to access the left atrium.
 17. Themethod of claim 1, wherein the valve member comprises a plurality ofcircular valve elements layered against each other, each valve elementhaving an aperture or one or more slits to permit passage of a medicalinstrument through the valve elements.
 18. The method of claim 1,wherein the valve member is configured to block the flow of bloodbetween the left atrium and right atrium in both directions when amedical instrument is not inserted through the valve member.
 19. Amethod, comprising: inserting a delivery catheter into the vasculatureof a patient, the delivery catheter comprising a sheath containing aseptal closure and port device in a compressed configuration; advancingat least a distal end portion of the sheath across an atrial septum ofthe patient's heart; deploying the closure and port device from thesheath such that a central portion of the closure and port deviceextends through an orifice in the atrial septum and first and secondopposing end portions of the closure and port device are deployed onopposite sides of the septum, which is compressed between the first andsecond end portions, and wherein the closure and port device isconfigured to block at least the flow of blood from the left to theright atrium; removing the delivery catheter from the vasculature of thepatient; and after removing the delivery catheter from the patient,inserting a medical instrument through the closure and port device andperforming a medical procedure in the left side of the heart using themedical instrument.
 20. The method of claim 19, wherein the closure andport device further comprises a valve member, wherein the valve membercomprise a plurality of flaps, each comprising an angular segment havingan outer circumferential edge portion and two radially extending edgeportions, the circumferential edge portion secured to the first endportion and each radially extending edge portion placed in anoverlapping relationship with an adjacent radially extending edgeportion of an adjacent flap, wherein the medical instrument can beinserted through the flaps to access the left atrium.